This report first appeared in the March 2012 print edition of DOTmed Business News.

Although the public seldom thinks about sterilizers, they are one of the most important parts of maintaining a safe medical facility. Without a properly functioning sterilizer, patients are at risk of contracting potentially life-threatening infections.

Depending on the type, manufacturer and size, a new sterilizer can cost anywhere from $50,000 to well over $300,000.



Mount Sinai Hospital in New York currently uses five steam and eight low-temperature sterilizers, all of which were purchased new, says Binchu John, the hospital’s sterilizing processing department director. Each unit typically runs between 11 and 15 loads per day. When one of the systems malfunctions, the facility utilizes its service contract and calls the manufacturer to come in and fix it. “Do not replace sterilizers unless [they’re] beyond repair,” says John.

With proper maintenance, health care facilities will have over a decade to make a return on their investment. There are many ways an end-user can extend the life of their sterilizer equipment. But one of the most important is to regularly perform preventive maintenance, such as cleansing every sterilizer with a liquid cleaner.

“If you run six cycles a day, then you should clean it once a week; if you run three cycles a day, you should clean it every two weeks,” says Shlomo Savyon, president of Alfa Medical, a sterilizer refurbishing, sales and service company. “You should run a cycle without any instruments—just with the liquid cleaner—and that will clean the pipes, the valves [and] it will coat the internal components to avoid rust and scaling.”

Sterilizer becoming fertile again
According to “Sterilization Equipment and Supplies - Global Strategic Business Report,” published by Global Industry Analysts in October 2011, the growth of the global sterilization equipment and supplies market slowed in 2009 due to the economic recession, which caused many hospitals to postpone buying new medical equipment. In 2010, however, the market experienced growth, driven largely by the increasing demand for infection control.

Moving forward, the report predicts that the global sterilization equipment and supplies market will be fueled by the necessity to replace or upgrade old equipment in order to stay technologically up-to-date. In addition, the anticipated increase in surgeries will create more of a demand for sterilization equipment in the future.

Low-temperature in high demand
Out of all the different methods available, gas plasma sterilization—a type of low-temperature sterilization—was determined to be the fastest growing segment of the market with yearly sales at a compound annual growth rate of nearly 9 percent, according to the Global Industry Analysts report.

The popularity of low-temperature sterilizers is in part due to the equipment’s ability to sterilize a wide array of materials, including items that wouldn’t tolerate high heat sterilization. Within the realm of low-temperature, some changes have taken place.

“Ethylene oxide sterilizers were the standard for devices requiring low-temperature processing,” says Renee Brown, product manager of low temperature sterilizers for STERIS, a sterilizer manufacturer, “but recently, there has been a shift away from ethylene oxide to other low temperature modalities such as hydrogen peroxide sterilization, which offers short cycle times and increased productivity.”


Low-temperature sterilizers include the Amsco V-Pro, launched by STERIS toward the end of 2011, which offers three different cycle options—25, 35 and 55 minutes—depending on the type of instruments that are being sterilized and a line of Sterrad Systems by Advanced Sterilization Products (a Johnson & Johnson company), which use low-temperature hydrogen peroxide gas plasma sterilization technology.

Refurbished keeps hospitals humming
For many facilities with tight budgets, shopping for refurbished units has become an attractive alternative. When a sterilizer is in the process of being refurbished, it must be returned to the operating characteristics that were set by its original manufacturer. Without FDA approval, a refurbisher cannot add any new features onto a system. With that reassurance, dealing with a reputable refurb company can save big money.

“Versus new, you’re going to see a savings of about 30 to 50 percent,” says Clay Morris, sales manager of Auxo Medical.

A provider of remanufactured sterilizers, Auxo Medical says its customer base consists of mainly surgery centers, although it also sells to hospitals, medical facilities and laboratories. Jay Crabtree, the company’s president, says he saw “significant growth” in sales last year.

“In the past couple years, even some smaller medical centers that typically wouldn’t consider refurbished equipment have really given remanufactured and refurbished equipment—especially in sterilization—a second look and a lot more consideration,” says Morris.

“Surgery centers have typically looked at return on capital, but now even some of the smaller regional hospitals are starting to say that they might be able to get a better return on their investment as well,” Crabtree says.

Digitalization and terminal sterilization
Similar to many other sectors, with radiography being a prime example, sterilizers are trending more and more toward digital technology.

According to Alfa Medical’s Savyon, the first digital/automatic sterilizer was the Validator, created by Pelton & Crane approximately two decades ago. Automatic sterilizers, as opposed to manual ones, are often equipped with high-tech features such as self-diagnostic software, display codes for troubleshooting assistance, water guards to avoid leaking condensation, and extra valve ports to speed up the venting process.

Another trend, according to Barbara Trattler, ASP’s director of clinical education, is that an increasing amount of medical facilities are using terminal sterilization, as opposed to immediate-use sterilization (previously known as flash sterilization). The former refers to the process of instruments being sterilized within some sort of packaging, enabling them to be stored for future use. The latter describes when unwrapped instruments are exposed to a steam sterilization cycle and then used right away.

“Sterile processing leaders are taking responsibility for ensuring their facility has the processes in place to meet current standards for best practices in sterilization,” says Trattler. “This has resulted in a focus on minimizing ‘immediate-use sterilization,’ which, as the name suggests, requires the immediate use of the processed device. Terminal sterilization allows health care facilities the flexibility of having dry, packaged devices delivered to the OR for use in a scheduled procedure or stored for use at a later time.”

Steady growth to come
In the coming years, Savyon forecasts that sterilizer technology’s move to digital will drive prices up. “The smarter you make the sterilizer, the more expensive it’s going to be,” he says.

Trattler feels that the need for better sterilization documentation methods will increase in the future. “For purposes of traceability and protection for both the patient and health care facility, documentation and record-keeping are essential, as they provide the data you need should an infection occur,” she says.

Michael Cain, senior product marketing manager of N.A. Sterilization for Getinge USA—a sterilizer manufacture—is certain that although low-temperature sterilizers are on the rise, their steam counterparts are here to stay. “The steam sterilization segment looks stable for years to come, despite increases in low-temperature processes,” he says.

According to Crabtree, steam sterilizers are not expected to introduce any new groundbreaking technology in the future. “It’s a pretty mature market in a lot of ways, the technology and the science behind steam sterilization hasn’t changed a great deal, and there’s not too many ‘gee-whiz’ features you can add to a steam sterilizer these days,” he says. “Like in lights, you can go from halogen to LED, which is a big change. You’re not going find that sort of change when you’re talking about sterilization.”

DOTmed Registered 2012 - Sterilizers Companies

Names in boldface are Premium Listings.
Domestic
Mitchell Dailey, Biomedical Professional Services, AL
George Perez, PES Medical, CA
James Graham, STS North America, NY
Rich Cram, World Medical Equipment, WA
Clay Morris, Auxo Medical, VA
DOTmed Certified
DOTmed 100
James Vollbracht, Strategic Surgical Solutions, LLC, WI
DOTmed Certified
Darren Walker, Duraline Systems, LLC, NY
DOTmed Certified
Steve Rice, Plaza Medical, CO
DOTmed Certified
Monte Montain, Alternative Source Medical, IL
DOTmed Certified
Bob Gaw, PRN, MA
DOTmed Certified
Jedrix Aquino, ASP, CA
Lisa Vanasco, Ready Medical, CA
Debbie Rice, Asset Equipment Store, FL
James Ruggiero, Mercury Medical, FL
Jim Gabalski, GETINGE, NY
Shlomo Savyon, Alfa Medical, NY
Robin Baum, STERIS Corporation, OH
Jamie Crowley, Midbrook Medical, MI
Darren Wennen, SterilMed, MN
Dave French, Mediquip Parts Plus, MO
Robert Gorsuch, Eichenauer Heating Elements, NH
Kevin Blaser, Coast to Coast Medical, MA
Elry Phillips, Veterinary Products Distributor, AR
Brant Gard, BLSS, CA
Ray Smith, LANCER Medical Services, Inc, CA
Israel Miranda, Pacific Diagnostic Inc, CA
George Perez, PES Medical, CA
Alda Clemmey, Saffire Medical, MA
DOTmed Certified
DOTmed 100
John Gladstein, Medical Device Depot, MD
DOTmed Certified
Lawrence Maroney, Integris Equipment, NY
DOTmed Certified
Krista Kalweit, MERCO, VA